Sales rep objected to off-label marketing of drug, but can’t prove FCA retaliation

By Joy Waltemath

By Dave Strausfeld, J.D.

A pharmaceutical sales rep who objected to what he saw as off-label marketing of a drug was unable to prove he was fired in violation of the False Claims Act, held the First Circuit, affirming summary judgment for the pharmaceutical company. The sales rep did not assert that his disagreements with his supervisor concerned the actual submission of false claims to the government, and without connecting his whistleblowing to an actual false claim he fell outside the scope of the FCA’s anti-retaliation provision. The sales rep and a colleague also could not move forward on their qui tam claim (U.S. ex rel. Booker v. Pfizer, Inc., January 30, 2017, Lynch, S.).

Two former sales reps contended that the pharmaceutical company Pfizer unlawfully marketed the drug Geodon for off-label uses, resulting in the filing of false claims with government programs like Medicaid. One of the sales reps also maintained he was fired for blowing the whistle on this conduct.

No actual false claim. Agreeing with the lower court, the First Circuit held that the sales reps could not move forward with their qui tam claim because they lacked evidence of any actual false claim. FCA liability requires a false claim for payment filed with the government.

Fell “far short.” Here, there was no evidence any actual false claim had resulted from the alleged off-label promotion of Geodon, a drug that is FDA-approved as a treatment for schizophrenia and bipolar disorder. After six years of litigation, the sales reps’ only evidence of false claims was data showing how much money Medicaid expended for pediatric prescriptions (an off-label use) of Geodon during a certain time period. This aggregate expenditure data fell “far short” of the evidence that would be needed to prove a false claim, because the sales reps did not identify any specific entities who submitted claims, much less times, amounts, and circumstances. Thus, even assuming Geodon was promoted for off-label uses (which the company vigorously disputed), there was no evidence any false claim resulted.

Because the sales reps lacked evidence of actual false claims submitted to the government, their data “is woefully inadequate” to support their qui tam claim, the appeals court concluded.

FCA retaliation. As for retaliation, one of the sales reps contended he was fired for complaining to his superiors that the company was continuing to promote Geodon for off-label uses, despite the company’s promise in a 2009 settlement with the U.S. Department of Justice to cease such conduct. According to his allegations, sales representatives were instructed to promote the drug for conditions such as depression and overt anger, though Geodon is not FDA-approved for those uses.

The downfall of the sales rep’s retaliation claim was that he did not raise objection to any actual false claim for payment. In the appeals court’s words: “Evidence that an employee objected to or reported receipt of instructions to promote a drug’s off-label use, absent any evidence that those objections or reports concerned FCA-violating activity such as the submission of false claims, cannot show at the summary judgment stage that the employee engaged in conduct protected by the FCA.”

Put differently, because the sales rep did not assert that his disagreements with his superiors “concerned the submission of false claims,” he fell outside the scope of the FCA’s anti-retaliation provision, the First Circuit held.

Source:: Sales rep objected to off-label marketing of drug, but can’t prove FCA retaliation